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Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)DiaDeaNCT03314883

Diaphragmatic Ultrasound in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF)

A study testing D-US ARF in people with Acute Hypoxic - Hypercapnic Respiratory Failure (ARF), run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mortality of acute hypoxic - hypercapnic respiratory failure (ARF) patients underwent invasive mechanical ventilation is demonstrated to be higher than in patients who underwent only non invasive mechanical ventilation (NIV). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
D-US ARF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteItaly
Study dates
9 Oct 2017to 4 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • respiratory failure resulting in respiratory acidosis to be treated with NIV
  • Age> = 18 years

Who cannot join

  • acute pulmonary edema
  • coexisting interstitial pathologies
  • neuromuscular pathologies
  • thoracic cage's deformity
  • previous diaphragmatic paralysis
  • hemodynamic instability
Show all 12Show fewer
  • intracranial hypertension
  • pregnancy
  • absolute contraindications to NIV
  • need for immediate intubation,
  • recent thoracotomy
  • presence of pneumothorax or pneumomediastinum

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • A.O.U Maggiore della Carità

    Novara, 28100

Other trials in Italy

About this study

Official title: Ultrasound Diaphragmatic Evaluation in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF) Patients Undergoing Non Invasive Ventilation: A Pilot Feasibility Study

Mortality of acute hypoxic - hypercapnic respiratory failure (ARF) patients underwent invasive mechanical ventilation is demonstrated to be higher than in patients who underwent only non invasive mechanical ventilation (NIV).

There is an increased need to detect more predictive factors for NIV failure, in order to better identify patients most at risk of facing negative outcomes.

Read more

The aim of this experimental pilot study is to evaluate the feasibility of the ultrasound of diaphragm in ARF patients underwent non invasive mechanical ventilation ( primary endpoint ).

Furthermore the secondary aim is to observe any relationship between diaphragmatic function (excursion), diaphragmatic thickening and the timing of arterial blood gases (ABGs) compensation in patients with ARF undergoing NIV treatment; additional outcomes are: correlation with dyspnea level, time of mechanical ventilation, NIV failure, rate of tracheostomy, length of stay in ICU and in-hospital and 90-day mortality.

Read the detailed description

Inclusion criteria: respiratory failure resulting in respiratory acidosis to be treated with NIV, age> = 18 years

Exclusion criteria: acute pulmonary edema, coexisting interstitial pathologies, neuromuscular pathologies, thoracic cage's deformity, previous diaphragmatic paralysis, hemodynamic instability, intracranial hypertension, pregnancy, absolute contraindications to NIV, need for immediate intubation, recent thoracotomy, presence of pneumothorax or pneumomediastinum.

After patient's triage, transfer to Shock Room and primary assessment by emergency department staff ,diaphragmatic ultrasound is performed when NIV indication is given.

NIV is delivered with a facial mask; ventilation is set in NIV application, pressure support mode. Positive end expiratory pressure (PEEP) and Inspired oxygen fraction (FiO2) are adjusted to obtain a peripheral oxygen saturation (Spo2) between 88-92%. The pressure support is set to achieve a target volume of between 6-8 (ml / kg) and a respiratory rate < 30 respiratory acts per minute.

Respectively one and two hours after starting NIV, diaphragmatic ultrasonography and ABGs analysis are again performed.

NIV failure criteria are defined by the need for endotracheal intubation or by death.

Criteria for NIV failure: unchanging or worsening blood gases despite NIV; need to protect airways due to neurological deterioration or massive secretions; haemodynamic instability or major electrocardiographic abnormalities; uncontrolled dyspnea and NIV intolerance/ refusal.

General measures On admission clinical severity is recorded by Glasgow Coma Scale (GCS), Acute Physiology and Chronic Health Evaluation II Score (APACHE II).

ABGs values ( PH, arterial oxygen tension (paO2), arterial carbon dioxide tension (paCo2), paO2/FiO2, bicarbonates (HCO3), lactate) will be recorded before NIV, at 1 hour and 2 hours later.

Chest X-ray and peripheral blood sample (hemochrome with band cell count, C-reactive protein (CRP) and electrolytes) will be performed within 24 hours of admission.

The presence of pneumonia, sepsis and previous treatment with systemic or inhaled steroids will be recorded.

Diaphragm Ultrasound

Ultrasound evaluation of diaphragm function is performed on admission before starting NIV, 1 hour and 2 hours later.

Diaphragmatic function is assessed by a B-Mode ultrasound device connected to a linear probe ( 7-12 MHz) at the patient's bedside.

Measurements are performed on a patient in supine position with a recessed back angle between 20 and 40 degrees.

Probe position is set between 8th and 10th intercostal space on the mid axillary line to find the apposition zone of the diaphragm, where lung, diaphragm and abdominal parenchyma are identifiable.

Diaphragmatic thickness is measured at end-inspiration ( Ti) and end- expiration (Te).

The percentage change in diaphragmatic thickness (ΔTdi) is calculated as follows:

ΔTdi % = (Ti- Te) / Te * 100 Measurements are performed three times and the average value of the three measurements is considered.

Diaphragmatic excursion is also evaluated.

Statistical analysis As it is an experimental pilot feasibility study, 20 patients will be initially enrolled.

Descriptive statistics for continuous variables will be presented as median and interquartile. Non-parametric continuous variables will be evaluated by non-parametric Wilcoxon test (Mann-Whitney).

Categorical variables will be evaluated by chi-square or Fisher's test.

The influence of diaphragmatic thickening and muscle thickness on NIV failure, mortality and hospitalization's days wil be assessed through correlation analysis A P-value <0.05 will be considered significant.

Being tested
D-US ARF
Keywords
Ultrasound, Diaphragm, Non Invasive Ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D-US ARFDiagnostic test

    Diaphragm ultrasound evaluation in acute hypoxic - hypercapnic respiratory failure (ARF) patients undergoing non invasive ventilation, with regard to thickening (%) and excursion (millimeters)

Study groups in NCT03314883
Study groupRoleWhat they receive
D-US ARFExperimentalDiaphragmatic evaluation, i.e thickening fraction (%) and excursion (millimeters), will be performed 3 times in the first two hours after acute hypoxic - hypercapnic respiratory failure (ARF) patients admission
Receives: Diagnostic Test: D-US ARF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of diaphragm ultrasound function evaluation (excursion and thickening) in acute hypoxic - hypercapnic respiratory failure (ARF) during the first two hours after emergency department admission.

    Ultrasound will be performed before starting NIV, after 1 and 2 two hours of NIV application

    Measured: 2 hours

Secondary outcomes (14)
  1. Arterial blood carbon dioxide (PaCO2) compensation evaluation

    PaCO2 at time of starting NIV, after one hour from NIV application and after two hours of NIV application

    Measured: 0 hour

  2. Arterial blood carbon dioxide (PaCO2) compensation evaluation

    PaCO2 at time of starting NIV, after one hour from NIV application

    Measured: 1 hour

  3. Arterial blood carbon dioxide (PaCO2) compensation evaluation

    PaCO2 after two hours from NIV application

    Measured: 2 hours

  4. Monitoring diaphragmatic function in terms of thickening at 0 hour

    Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100

    Measured: 0 hour

  5. Monitoring diaphragmatic function in terms of thickening at 1 hour

    Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100

    Measured: 1 hour

  6. Monitoring diaphragmatic function in terms of thickening at 2 hours

    Diaphragmatic thickening (%) [(inspiratory thickness - expiratory thickness)]/expiratory thickness * 100

    Measured: 2 hours

  7. Monitoring diaphragmatic function in terms of excursion at 0 hour

    Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath

    Measured: 0 hour

  8. Monitoring diaphragmatic function in terms of excursion at 1 hour

    Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath

    Measured: 1 hour

  9. Monitoring diaphragmatic function in terms of excursion at 2 hours

    Diaphragmatic excursion (millimeters) computed as diaphragmatic displacement during breath

    Measured: 2 hours

  10. Days spent in intensive care unit

    Amount of days spent in ICU

    Measured: 28 days

  11. Days spent in in hospital

    Amount of days spent in hospital

    Measured: 90 days

  12. dyspnea level at 0 hour

    dyspnea level evaluated via visual analogical scale

    Measured: 0 hour

  13. dyspnea level at 1 hour

    dyspnea level evaluated via visual analogical scale

    Measured: 1 hour

  14. dyspnea level at 2 hours

    dyspnea level evaluated via visual analogical scale

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2017
  2. Study start9 Oct 2017
  3. Primary completion4 May 2018
  4. Study completion4 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03314883
Sponsor's protocol ID
CE 112/17
Acronym
DiaDea
Status last verified
May 2018
First submitted
22 Sep 2017
Last updated
7 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cammarota G, Sguazzotti I, Zanoni M, Messina A, Colombo D, Vignazia GL, Vetrugno L, Garofalo E, Bruni A, Navalesi P, Avanzi GC, Della Corte F, Volpicelli G, Vaschetto R. Diaphragmatic Ultrasound Assessment in Subjects With Acute Hypercapnic Respiratory Failure Admitted to the Emergency Department. Respir Care. 2019 Dec;64(12):1469-1477. doi: 10.4187/respcare.06803. Epub 2019 Aug 27.

    PubMed 31455684

Questions about this trial

What is this clinical trial studying?

A study testing D-US ARF in people with Acute Hypoxic - Hypercapnic Respiratory Failure (ARF), run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of diaphragm ultrasound function evaluation (excursion and thickening) in acute hypoxic - hypercapnic respiratory failure (ARF) during the first two hours after emergency department admission. (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.

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